How Human Factors Lead to Medical Device Adverse Events
By Suzanne Rich, RN, CT, MA FOLLOW US ON TWITTER
- operation that’s intuitive and doesn’t require frequent reference to an instruction manual
- easy-to-read displays
- easy-to-use controls
- appropriate connections of device-to-device and device-to-outlet for safe use
- effective alarms
- easy repair and maintenance.2
Consider three major areas when evaluating medical-device-related adverse events from a human factors perspective:
- user characteristics, including the person’s abilities and training and her expectations of the device
- device design considerations, which focus on the device-user interface, including
instructions for use
- the environment in which the device
is used, including the lighting, noise,
distractions, and time constraints.1 , 2
Training and expectations
Looking at design
- The user can see the device displays, labels, or markings.
- Display screens are easy to see, have clear contrast, and are bright enough to be seen without glare.
- The font is large enough to be read by all users.
- The user can easily hear and interpret alarms.
- The sequence of sounds is appropriate in volume, frequency, tone, and pitch.
- The alarm’s timing clearly defines the acuity of the warning and gives the user enough time to make adjustments and corrections.
- The device’s components can be connected easily.
- The device’s components can’t be easily disconnected or connected by mistake. (Problems have been reported with some electrodes, cables, and I.V. tubing.)
- The device’s components can be connected so that the user feels a “click” to help ensure a proper connection.
- The user can feel the controls of knobs, buttons, switches, and keypads.
Consider the environment
- staff with heavy workloads, such as multiple high-acuity patients
- staff working double shifts
- float and temporary staff who may be unfamiliar with the unit’s equipment
- different brands or models of the same type of equipment within the same facility.
TROUBLING HUMAN FACTORS PROBLEMS
1. FDA’s Human Factors Program: Promoting safety in medical device use. http://www.fda.gov/cdrh/humanfactors/index.html. Accessed March
2. Sawyer D. Do it by design: An introduction to human factors. http://www.fda.gov/cdrh/humfac/doit.html. Accessed March 27, 2008.
3. Rich S. Medical devices and patient safety: The role of human factors. Association for Vascular Access Pre-Conference, Indianapolis, Ind., September 8, 2006.
4. Food and Drug Administration. Manufacturer and User Facility Device Experience (MAUDE). http://www.fda.gov/cdrh/maude.html. Accessed March 27, 2008.
5. Eakle M, et al. Luer-lock misconnects can be deadly. Nursing2005. 35(9):73, September 2005.
Source ~ FDA